A drug manufacturer said that more than 11,000 bottles of prescription blood pressure medication are under recalls, according to a notice published this week on the Food and Drug Administration’s (FDA) website.
The notice said that chlorthalidone tablets, USP, in 25-milligram doses, are under recall for “failed dissolution specifications.” It added that 11,460 bottles are under recall, and the products have an April 2027 expiration date.
The recall impacts 100-count tablet bottles with the batch number, RISA24001, and 1,000-count tablet bottles with the batch number, RISB24002, it said.
The firm that made the medication, India-based Inventia Healthcare Limited, said the recall was initiated on June 5. The FDA, which hasn’t classified the recall yet, published the notice on its website this week, according to an Epoch Times review of its recall database.
A “failed dissolution specification,” according to U.S. health officials, is when a medication did not dissolve or break down during laboratory testing, which may mean that a patient would not be able to absorb the drug effectively. It’s a form of quality control and allows companies to formulate dosage ranges for medications. The No. 1 reason for drug recalls over the past several years is due to the issue, said the FDA in a report in 2023.
No press release was issued for the recall, which the alert said is ongoing and nationwide. The company that distributed the chlorthalidone tablets is New Jersey-based Rising Pharma Holdings, Inc.
The FDA and Inventia Healthcare have not issued a statement on the possible health risks associated with consuming the recalled drugs.
The medication is generally prescribed for high blood pressure, or hypertension, a common health condition that impacts the arteries, according to the Mayo Clinic. It is also used to treat fluid retention, also called edema, that is caused by liver disease, kidney disease, congestive heart failure, or treatments with steroid- or hormone-based medicines.
According to statistics provided by the drug database ClinCalc, the medication was prescribed more than 5 million times in 2023 and has more than 1.4 million estimated patients.
The recall comes after more than 15,000 bottles of amlodipine and olmesartan medoxomil tablets in 5mg/40mg-doses were recalled nationwide also due to failed dissolution specifications, according to an FDA-published notice. That recall was initiated in May but was classified as Class II by the agency on June 2.
The medication was made by India-based Alkem Laboratories Ltd. and distributed by New Jersey-based Ascend Laboratories, LLC, it said. The bottles have an expiration date of Oct. 31, 2027, and they come in 30-count bottles.